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Signed in accordance with a resolution of the directors made pursuant to section 306(3) of the Corporations Act 2001 . On behalf of the directors Spyridon “Spyros” Papapetropoulos President, Chief Executive

Key Takeaway: Bionomics Limited has released its Half-Year Report for the period ending December 31, 2023. The report highlights a decrease in cash reserves and an operating loss after tax, although Bionomics has shown progress in its clinical trials, particularly for the drug candidate BNC210. Following a favorable End-of-Phase 2 meeting with the FDA, the company plans to initiate a Phase 3 study for BNC210, pending funding. The report details the company's financial situation and outlines the principal activities and future plans regarding its CNS-focused drug pipeline.

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Half-Year Report 31 December 2023
Contents Page
Directors' Report 2
Auditor's Independence Declaration 8
Consolidated Statement of Profit or Loss and Other Comprehensive Income 9
Consolidated Statement of Financial Position 10
Consolidated Statement of Changes in Equity 11
Consolidated Statement of Cash Flows 12
Notes to the Consolidated Financial Statements 13
Directors' Declaration 19
Independent Auditor's Review Report to the Members 20
This interim financial report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report is to be read in conjunction with the annual report for the year ended 30 June 2023.
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Directors present their report on the consolidated entity (the Group) consisting of Bionomics Limited (the Company) and the entities it controlled at the end of, or during, the half-year that ended 31 December 2023. To comply with the provisions of the Corporations Act 2001, the Directors' report is as follows:
The names of the Directors of the Company during or since the end of the half-year:
-Mr Alan Fisher, Non-Executive Chair
-Mr David Wilson, Non-Executive Director
-Dr Jane Ryan, Non-Executive Director
-Mr Aaron Weaver, Non-Executive Director
-Dr Miles Davies, Non-Executive Director
-Dr Errol De Souza, Non-Executive Director resigned 30 November 2023
-Dr Spyridon Papapetropoulos, President and Chief Executive Officer
Principal Activities
The group's principal activities during the period include developing novel drug candidates focused on treating central nervous system disorders (CNS).
The Directors do not propose any recommendation for dividends for the current financial year.
REVIEW OF OPERATING RESULTS
Cash during the half-year to 31 December 2023, decreased by $3,383,992 to $14,866,263 at 31 December 2023, from $18,250,255 at 30 June 2023. The decrease is due to net decrease in cash from activities during the half-year ended 31 December 2023 of $3,015,862 and a foreign exchange loss from the effects of exchange rate changes on the balance of cash held in foreign currencies at 31 December 2023 of $368,130. The net decrease in cash from activities is due to the following:
-net cash used in operating activities of $14,306,762 due to payments to suppliers and employees of $14,920,162 and payments for finance costs of $14,159, offset by the receipt of research & development tax incentive of $627,559.
-net cash inflows from investing activities of $213,827 due to interest income received; and
-net cash inflows from financing activities of $11,077,073, due to net proceeds from share issues of $10,020,033, proceeds from other borrowings of $1,141,815 offset by principal element of lease payments of $84,775.
The operating loss after tax for the half-year ended 31 December 2023 decreased to $15,368,459, compared to $16,207,967 for the half-year ended 31 December 2022, primarily as a result of:
-Interest income for the half-year increased by $24,076 to $216,346, compared to $192,270 for the previous half-year. The increase is primarily due to an increase in interest rates.
-Other income for the half-year increased by $12,375 to $145,159, compared to $132,784 for the previous half-year. The increase is primarily due to an increase in the Australian
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Government research and development tax incentive income for the half-year, compared to the previous half-year.
-Other gains and (losses) for the half-year decreased by $892,597 to a net loss of $(478,155), compared to a net gain of $414,442 for the previous half-year. The decrease is primarily due to:
oa decrease in net realised and unrealised foreign currency gain/(loss) of $1,013,594 to a net loss $(559,645), compared to a net gain of $453,949 for the previous half-year.
oan increase in net gain/(loss) arising on changes in fair value of contingent consideration of $120,997 to a gain of $81,490, compared to a net loss of $(39,507) for the previous half-year.
-Research and development expenses for the half-year decreased by $3,030,397 to $7,729,756, compared to $10,760,153 for the previous half-year, as a result of only one clinical trial (ATTUNE Phase 2b PTSD clinical trial), compared to two clinical trials during the previous half-year (ATTUNE Phase 2b PTSD and PREVAIL Phase 2a clinical trials).
-Administrative expenses for the half-year increased by $1,963,642 to $6,044,654, compared to $4,081,012 for the previous half-year, primarily due to:
oan increase in costs for new activities:
ASX delisting, which occurred on close of business 28 August 2023, Bionomics is now only listed on NASDAQ;
a share issue that did not occur; and
current fund-raising activities that have not been finalised.
oan increase in staff expenses following the appointment of the CEO from 5 January 2023 and pay increases for staff effective 1 July 2023;
oan increase in use of consultants as activities have increased;
oan increase in investor relation fees, due to an increase in investor relation activities; and
oan increase in employee share-based payment expenses related to the amortisation of fair value of share options over their vesting period.
oa decrease in Director fees due to a change in positions for Dr Errol De Souza, as a result of the appointment of the new CEO on 5 January 2023 from Executive Chairman to Non-Executive Director;
oa decrease in staff recruiting costs as there have been no staff recruited during the six months ended 31 December 2023; and
oa decrease in accounting fees for assistance with the US 20-f financial statements, as the filing during October 2023 was the Company's second filing.
-Compliance expenses decreased by $629,381 to $1,454,552 compared to $2,083,933 for the previous half-year, primarily due to:
oa decrease in D&O insurance as a result of a decrease in the annual premium;
oa decrease in ASX fees, as a result of delisting from the ASX; and
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oan increase in audit fees.
REVIEW OF OPERATIONS
Bionomics is a clinical-stage biotechnology company developing novel, allosteric, and orthosteric ion channel modulators designed to transform the lives of patients suffering from serious CNS disorders with high unmet medical need.
Ion Channel Expertise to Drive Growth
Ion channels serve as essential mediators of physiological function in the CNS, and the modulation of ion channels influences neurotransmission that affects downstream signaling in the brain. The 7 nicotinic acetylcholine ( nACh ) receptor ( 7 receptor ) is an ion channel that plays an important role in modulating emotional responses and cognitive performance. Utilising our expertise in ion channel biology and translational medicine, we are developing orally active small molecule negative allosteric modulators ( NAMs ) and positive allosteric modulators ( PAMs ) of the 7 receptor to treat anxiety-related disorders and cognitive dysfunction disorders, respectively. Bionomics' CNS pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels and the 2nd generation 7 receptor NAM program. The Company is seeking funding and strategic partners to advance its preclinical assets.
BNC210 Proprietary Pipeline Expansion and Continued Development
Bionomics is advancing its lead product candidate, BNC210, an oral, proprietary selective NAM of the 7 receptor for the acute treatment of SAD and chronic treatment of PTSD.
In December 2022, the Company completed its Phase 2 PREVAIL Study (NCT05193409) to evaluate BNC210 for the acute treatment of SAD. The PREVAIL Study was a randomised, double-blind, placebo-controlled, multi-centre Phase 2 clinical trial with a single dose treatment in 151 adult patients with SAD. The PREVAIL Study topline data were reported on 19 December 2022. The Company believes that the PREVAIL data will support the progression of BNC210 into Phase 3. On 13 September 2023, an End-of-Phase 2 meeting was held with the US Food and Drug Administration (FDA) to review results from the PREVAIL Study and to obtain feedback on a proposed Phase 3 registrational program that would support the submission of a new drug application ( NDA ) for BNC210 for the treatment of SAD. Following what the company believes was a successful End-of-Phase 2 meeting and the written comments received by the FDA following the meeting, the Company is planning to initiate a Phase 3 study in SAD during the quarter ending 31 March 2024 contingent upon securing funds to execute on the program.
On 27 September 2023, the company also announced the results of ATTUNE study which was a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomised 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The trial met its primary endpoint of change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to Week 12 (p=0.048). A statistically significant change in CAPS-5 score was also observed at Week 4 (p=0.016) and at Week 8 (p=0.015).
Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial. Specifically, BNC210 led to significant improvements at Week 12 in depressive symptoms (p=0.041) and sleep (p=0.039) as measured by Montgomery- sberg Depression Rating Scale (MADRS) and Insomnia Severity Index (ISI), respectively. BNC210 also showed signals and trends across visits in the other secondary endpoints including the clinician and patient global impression - symptom severity (CGI-S, PGI-S) and the Sheehan Disability Scale (SDS).
Treatment with 900 mg twice daily BNC210 had a favourable safety and tolerability profile. The most common (>5% of subjects in each group) reported adverse events, including headache, nausea, and fatigue, which were consistent with previous studies with BNC210. A hepatic enzyme increase was observed in 14 (13.3%) patients treated with BNC210 vs 2 (0.19%) in the placebo group; the
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abnormal results were not associated with hepatic injury and in most cases were resolved without drug discontinuation. The Company plans to engage with the FDA to discuss the registrational path for BNC210 in PTSD.
The company has also identified several leads for a 2nd generation of an oral, proprietary selective NAM of the 7 receptor. The leads have the potential to offer significant advantages over BNC210 in terms of in vitro potency, in vivo efficacy and solubility with excellent selectivity. With the necessary resources, contingent upon securing funds, we anticipate nominating a development candidate within the next 12-18 months to initiate IND-enabling studies. These 2nd generation compounds, if successful, may enhance the company's ability for life-cycle management and exclusivity of the 7 receptor program.
Novel Approach in Large Market with Significant Unmet Need
There remains a significant unmet medical need for over 22 million patients in the US alone suffering from SAD and PTSD. Current pharmacological treatments include certain antidepressants and benzodiazepines, and there have been no new FDA-approved therapies in these indications in nearly two decades. These existing treatments have multiple shortcomings, such as a slow onset of action of antidepressants and significant side effects in both classes of drugs. BNC210 has been observed in clinical trials to have a fast onset of action and has demonstrated anti-anxiety and antidepressant effects but without many of the limiting side effects observed with the currently available medications.
Strong Ongoing Collaboration with MSD
The Company's expertise in ion channels and approach to developing allosteric modulators have been validated through its strategic partnership with Merck Sharpe & Dohme ( MSD , known as Merck in the US and Canada) for our 7 receptor PAM program, which targets a receptor that has garnered significant attention for treating cognitive deficits. This partnership enables Bionomics to maximise the value of its ion channel and chemistry platforms and develop transformative medicines for patients suffering from cognitive disorders such as Alzheimer's disease and other CNS conditions.
In 2014 Bionomics entered into an exclusive Research Collaboration and License Agreement with MSD to develop 7 Receptor PAM targeting cognitive dysfunction associated with Alzheimer's disease and other CNS conditions.
MSD funds all research and clinical development, and worldwide commercialisation of any resulting products. This collaboration generated payments of US$20M upfront and US$10M for a Phase 1 milestone. Bionomics is eligible to receive up to US$465M in additional milestone payments for certain development and commercial milestones plus royalties on net sales of licensed drugs.
The original lead molecule BNC375, a Type I 7 nAChR PAM, showed a robust and sustained dose-dependent efficacy over a broad dose range and across multiple cognitive animal models. MSD has subsequently developed MK-4334, a novel clinical candidate which, in early preclinical studies, has shown improved drug like and pharmacological properties relative to BNC375. In addition to Phase 1 safety, tolerability and clinical pharmacokinetics studies, clinical biomarker studies are ongoing to further evaluate the pharmacological response of 7 nAChR PAMs in humans. In addition to MK-4334 a second molecule that showed an improved potency profile in preclinical animal models was advanced by MSD under this collaboration into Phase 1 clinical trials.
Leveraging the Value of Legacy Oncology Assets
Bionomics continues limited activities to maximise the value of our legacy oncology programs through external funding of clinical development and divestment/out-licensing.
The Company entered an exclusive agreement to license its BNC101 oncology drug candidate to Carina Biotech (Carina) to develop Chimeric Antigen Receptor T cell (CAR-T) therapy, which harnesses the body's immune system to fight cancer. BNC101 is a first-in-class humanised monoclonal antibody to LGR5, which is overexpressed in cancer stem cells within solid tumors and has the potential to guide CAR-T therapeutic development. Under the worldwide exclusive License Agreement, Carina will fund all research and development activities. Bionomics is eligible to receive
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up to $118 million in clinical and development milestones plus royalty payments if Carina fully develops and markets the new therapy. In the event that Carina sub-licenses the CAR-T treatment, Bionomics is eligible to share in the sub-licensing revenues in early clinical development and receive a substantial double-digit portion of the revenues in the later stages of clinical development. On 24 January 2023, Carina announced that it had received an FDA Safe to Proceed Letter for a Phase 1/2a clinical trial of BNC101 CAR-T therapy for the treatment of advanced colorectal cancer. On 25 August 2023, Carina announced that patient screening for their Phase 1/2a study had commenced.
Bionomics remains focused on developing its ongoing clinical programs with BNC210 in SAD and PTSD. Bionomics is currently continuing start-up activities for a Phase 3 study in SAD planned to commence during the quarter ending 31 March 2024 contingent upon securing funds to execute the program. Bionomics is also preparing for regulatory interactions to discuss next steps in the PTSD development program and plans to engage with the FDA in the upcoming months.
Financing Activities
During September 2023 and December 2023 Cantor (who act as the Company's sales agent) sold under the US ATM Program, 2,533,739 ADSs (456,073,020 ordinary shares) raising gross proceeds of US$7,333,334 ($10,519,012). The net proceeds raised was $10,461,452 after deduction costs associated with the share issue of $965,246.
Since 31 December 2023 and up to the date of this report
-Cantor, during January 2024, sold under the US ATM Program, 1,257,578 ADSs (226,364,040 ordinary shares) raising gross proceeds of US$1,569,537. Net proceeds received after deducting Cantor's commission and the ADS issuance fee were US$1,522,450.
The net proceeds of the share issues, along with the existing cash and cash equivalents, are primarily being used to advance BNC210 through to the initiation and completion of the planned Phase 3 study in SAD, the evaluation of next development steps of BNC210 in PTSD, and for working capital for other research and development activities and general corporate purposes. Management continues to evaluate our capital requirements based on assumed activities and forecast expenditures.
Details about subsequent events are disclosed in Note 13 to the Half-year Report.
Auditor's independence declaration
A copy of the auditor's independence declaration, as required under section 307C of the Corporations Act 2001, is set out on page 8.
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Signed in accordance with a resolution of the directors made pursuant to section 306(3) of the Corporations Act 2001.
On behalf of the directors
Spyridon Spyros Papapetropoulos
President, Chief Executive Officer and Director
Dated at Adelaide this 15 March 2024
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Auditor's independence declaration to the directors of Bionomics Limited
As lead auditor for the review of the half year financial report of Bionomics Limited for the half year ended 31 December 2023, I declare to the best of my knowledge and belief, there have been:
a.No contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the review;
b.No contraventions of any applicable code of professional conduct in relation to the review; and
c.No non-audit services provided that contravene any applicable code of professional conduct in relation to the review.
This declaration is in respect of Bionomics Limited and the entities it controlled during the financial period.
A member firm of Ernst & Young Global Limited
Liability limited by a scheme approved under Professional Standards Legislation
Consolidated Statement of Profit or Loss and Other Comprehensive Income
for the half-year ended 31 December 2023
Half-year ended
Note 31 Dec 2023 31 Dec 2022
$ $
Continuing operations
Interest income 216,346 192,270
Other income 2 145,159 132,784
Other gains and (losses) 2 (478,155) 414,442
Expenses
Research and development expenses (7,729,756) (10,760,153)
Administration expenses (6,044,654) (4,081,012)
Occupancy expenses (111,936) (111,149)
Compliance expenses (1,454,552) (2,083,933)
Finance expenses 3 (17,546) (15,139)
(Loss) before tax (15,475,084) (16,311,890)
Income tax benefit 106,625 103,933
(Loss) for the period (15,368,459) (16,207,967)
Other comprehensive income, net of income tax
Items that may be reclassified subsequently to profit or loss:
(Loss)/Gain on exchange differences from translating foreign operations (214,434) 199,913
Total comprehensive (Loss) for the period (15,582,893) (16,008,054)
(Loss) per share from continuing operations : Cents Cents
Basic (loss) per share (0.9) (1.2)
Diluted (loss) per share (0.9) (1.2)

Frequently Asked Questions

What are the principal activities of Bionomics Limited?

Bionomics Limited focuses on developing novel drug candidates for central nervous system disorders.

Did Bionomics propose dividends for this financial year?

No, the Directors do not recommend any dividends for the current financial year.

What significant cash decrease occurred in Bionomics' report?

Cash decreased by $3,383,992, resulting in $14,866,263 by 31 December 2023.

What is the lead product candidate of Bionomics?

BNC210 is Bionomics' lead product candidate for treating Social Anxiety Disorder and PTSD.

When is Bionomics planning to start Phase 3 studies?

Bionomics plans to initiate Phase 3 studies in SAD by March 2024, pending funding.

Last updated: Mar 15, 2024